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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K983832
Device Name INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
Applicant
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA,  CA  94510
Applicant Contact DONNA WARD
Correspondent
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA,  CA  94510
Correspondent Contact DONNA WARD
Regulation Number874.1090
Classification Product Code
ETY  
Date Received10/30/1998
Decision Date 01/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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